Sequential Use of Nab-paclitaxel Plus Gemcitabine and mFOLFIRINOX as Neoadjuvant Chemotherapy for Resectable Pancreatic Cancer: A Randomized Control Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 324
- 试验地点
- 1
- 主要终点
- event-free survival (EFS)
研究概览
简要总结
The prognosis of pancreatic cancer is extremely poor. Current guidelines recommend Nab-paclitaxel, Gemcitabine and modified Folfirinox as the first-line chemotherapeutic regimen. Studies have shown that sequential chemotherapeutic regimen can effectively delay the drug resistance and improve the effect of chemotherapy. Here investigators intend to assess the effect of sequential treatment with Nab-paclitaxel plus Gemcitabine and modified Folfirinox as neoadjuvant chemotherapy for resectable pancreatic adenocarcinoma.
详细描述
Investigators chose resectable pancreatic adenocarcinoma patients. The planned treatment was given to the participants after randomization. Tumor size, event-free survival, overall survival, drugs related side effects and other endpoints events were recorded and analyzed, to assess the sequential treatment with Nab-paclitaxel plus Gemcitabine and modified Folfirinox could or couldn't benefit the prognosis of resectable pancreatic adenocarcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma (PDAC).
- •No evidence of distant metastasis (such as liver, peritoneum, lung) evaluated by abdominal contrast-enhanced CT, MRI, and chest CT. PET/CT or other imaging examinations would be used if necessary.
- •Initial assessment for definitive resectable tumors (resectability judgment is based on CT enhanced scan or magnetic resonance imaging, NCCN2018 first edition standard).
- •ECOG score 0 or
- •Serum creatinine level is normal, and serum total bilirubin level is less than 1.5 x ULN.
- •ALT and AST are less than 2 x ULN.
- •If biliary obstruction is observed, biliary decompression should be performed when the patient is randomly assigned to receive neoadjuvant chemotherapy.
- •Leukocyte count (> 3.5 x 10^6 /mL), neutrophil count (> 1.5 x 10^6 /mL), platelet count (> 80 x 10^6 /mL), hemoglobin (> 9 g/dL).
- •Signed informed consent.
排除标准
- •History of malignance treatment in the past, excluding basal and cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma
- •Tumor is a local recurrent lesion.
- •Imaging confirmed severe portal hypertension / cavernous transformation.
- •Gastric outlet obstruction
- •Respiratory failure requires supplementation of oxygen.
- •Immune deficiency syndrome, such as active tuberculosis and HIV infection.
- •Hematological precancerous diseases, such as myelodysplastic syndromes.
- •Major cardiovascular diseases (including myocardial infarction, unstable angina, congestive heart failure, severe uncontrolled arrhythmia) during the past six months of enrollment.
- •Evidence of clinical-related or previous interstitial lung disease, such as noninfectious pneumonia or pulmonary fibrosis, or baseline chest CT scan or chest X-ray findings
- •Previous or physical findings of central nervous system disease, except for adequately treated (e.g. primary brain tumors, uncontrolled seizures or strokes with standard medications)
- •Preexisting neuropathy > 1 (NCI CTCAE).
- •Allograft requires immunosuppressive therapy or other major immunosuppressive therapies.
- •Severe serious wounds, ulcers or fractures.
- •Confirmed coagulant disease.
- •Clinical evaluation is unacceptable.
研究组 & 干预措施
Neoadjuvant Chemotherapy
Patients receive the sequential neoadjuvant chemotherapy of AG regimen (nab-paclitaxel plus gemcitabine) and mFOLFIRINOX before resection.
干预措施: AG regimen (Drug)
Neoadjuvant Chemotherapy
Patients receive the sequential neoadjuvant chemotherapy of AG regimen (nab-paclitaxel plus gemcitabine) and mFOLFIRINOX before resection.
干预措施: mFolfirinox (Drug)
结局指标
主要结局
event-free survival (EFS)
时间窗: From randomization to any of the following events: progression of disease that precludes resection, local or distant recurrence, or death due to any cause, whichever occurs first. Up to approximately 60 months.
Event-Free Survival assessed by the investigator according to RECIST 1.1 by investigator, defined as the time from randomization to any of the following events: progression of disease that precludes resection, local or distant recurrence, or death due to any cause, whichever occurs first.
次要结局
- Overall survival(From randomization to death due to any cause. Up to approximately 60 months.)
- Objective response rate(From randomization to the end of neoadjuvant therapy. Up to approximately 60 months.)
- Carbohydrate antigen 19-9(Up to approximately 60 months)
- Serious adverse events incidence(Up to approximately 60 months)
研究者
Liang Tingbo
Director of HBP Surgery, The Second Affiliated Hospital Zhejiang University School of Medicine
Second Affiliated Hospital, School of Medicine, Zhejiang University